Regulatory Affairs Executive

2 weeks ago

Sari Ahmedabad Gujarat, India MEDICARE HYGIENE LTD Full time ₹ 14,40,000 - ₹ 19,20,000 per year
  • To document, prepared the Quality as well as various technical documents & co-ordinate approval from the Authorize Person as per the Policy of the company and in line with MDR& QMS Requirement..
  • To establish the Quality Management System in the company at all levels
  • System Management as per ISO 13485 Audits & NCR Closing
  • Make Internal Audit function as per the requirement of the Quality Systems
  • To co-ordinate within all functions as far as the Quality System is concern
  • Make document for Management Review meeting.
  • Provide Support Record/Documents to the QA Head about the functioning of the Quality Management Systems in the company during Management Review Meeting.
  • To co-ordinate and Prepared the corrective action against internal /External audit findings
  • To maintain Quality records pertaining to his function.
  • Prepared the required changes in implementing, maintaining and imparting the quality system & get Respective Approval from QA Head.
  • Control sample preservation & monitoring
  • Review of BMR
  • High Light System Related Deviation throughout Company & Report to QA Head.
  • Monitoring Objective of each Functions Records & get approval on monthly bases from authority.
  • Handling Complaint.
  • Issuance of Batch Through BMR/IPQC control Formats
  • Weekly verification of various Department.
  • Monitoring Schedule of all validation, calibration, stability, control sample, observation, Bio burden, Fumigation.
  • Prepared & Monitoring of Process Validation, machine validation etc.
  • Improve awareness among team member for effective IPQC.
  • Co-ordinate for Design Development, Post market surveillance, Risk management analysis, field safety corrective action etc.
  • Being an Active Participant for Continuous Improvement/various Product development activities.
  • Raising Change Note /Suggestion.
  • Maintaining Stock of Printed Documents.
  • Maintain & Monitoring of Monthly QC Report & BMR Status

Job Types: Full-time, Permanent

Pay: ₹30, ₹40,000.00 per month

Benefits:

  • Leave encashment
  • Paid sick time
  • Paid time off
  • Provident Fund

Work Location: In person

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